Resverlogix Commences Dosing in Phase II Clinical Trial
Resverlogix Corp. recently announced that the first patient has been randomized and dosing has commenced in the Phase III clinical trial BETonMACE with lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM). The primary outcome measure will assess the effect of apabetalone on time to first occurrence of Major Adverse Cardiovascular Events (MACE) in high-risk type 2 DM patients with CAD. In the primary outcome measure, MACE is narrowly defined as a single composite endpoint of cardiovascular death, or non-fatal myocardial infarction (MI), or stroke. All subjects will remain on a high-dose statin therapy (atorvastatin or rosuvastatin), with the experimental group receiving 200 mg/day of apabetalone in the form of 100-mg capsules twice daily. Additional trial details and updates can be found at: www.clinicaltrials.gov and/or www.clinicaltrialsregister.eu/.
“We are pleased to announce that dosing has commenced in BETonMACE only two weeks after of the opening of our first sites. Every team member has worked exceptionally hard to expedite the process with rigorous attention to detail,” said Dr. Michael Sweeney, Senior Vice President of Clinical Development.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is the first and only BET inhibitor selective for the second bromodomain (BD2) within the BET protein called BRD4. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with diseases such as high-risk cardiovascular disease (CVD), diabetes mellitus (DM), chronic kidney disease, Alzheimer’s disease, Orphan diseases, and peripheral artery disease, while maintaining a well described safety profile. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials, currently in a Phase III trial BETonMACE in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL). Resverlogix’s common shares trade on the Toronto Stock Exchange (TSX: RVX). For more information, visit www.resverlogix.com.
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